MEDTRONIC CRYOCATH LP ACHIEVE MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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Model Number 990063-020 |
Device Problem
Entrapment of Device (1212)
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Patient Problems
Physical Entrapment (2327); Blood Loss (2597)
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Event Date 08/23/2018 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that during a cryo ablation procedure, the mapping catheter could not be removed from the left superior pulmonary vein (lspv).A transesophageal echocardiogram (tee) was performed to confirm entrapment.The patient was taken into the operating room to remove the mapping catheter.The case was aborted and the patient was under general anesthesia.No further patient complications have been reported as a result of this event.Post procedure, the patient underwent a blood transfusion due to blood loss but is currently stable.
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Manufacturer Narrative
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Event summary: patient data files showed ten applications were performed with catheter 2af284/4062 the date of event.Patient file showed system notice (50003) was received indicating that the pressure was low in the system at application #1 and 2, most likely due to closed gas tank.The mapping catheter performance is not captured through patient data file.The case was aborted and the patient was under general anesthesia.It was reported that during a cryo ablation procedure, the mapping catheter could not be removed from the left superior pulmonary vein (lspv).The patient was taken into the operating room to remove the mapping catheter.The case was aborted and the patient was under general anesthesia.The mapping catheter was not returned for investigation.In conclusion, this is a case related to a clinical adverse event (entrapment).The reported issue could not be assessed through data analysis.There is no indication of relation of adverse event to the performance and malfunction of the product.The mapping catheter was not returned for investigation.The case was aborted while the patient was under general anesthesia.If information is provided in the future, a supplemental report will be issued.
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